SLEEPY JR- chamomilla, cina, chinchona officinalis, coffea cruda, nux vomica spray 
Silver Star Brands

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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NativeRemedies® Sleepy Jr.™

HPUS Active Ingredients:

Equal volumes of each ingredient: Chamomilla 6C, Cina 30C, Cinchona officinalis 30C, Coffea cruda 6C, Nux vomica 30C.

Uses*:

Homeopathic remedy to relieve occasional sleeplessness and restlessness in toddlers and children.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Alternatively, the spray may be dispensed into a little water or juice. Use every night 15 minutes before bedtime until a regular sleep pattern is established. Repeat up to 3 times during the night if necessary. Children 18 months to 3 years: 1 pump spray. Chidlren over 3 years: 2 pump sprays.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. Fore more information, visit us at www.nativeremedies.com. Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding, ask a health professional before use.

Relieves occasional sleeplessness & restlessness in toddlers & children

Sleepy Jr

SLEEPY JR 
chamomilla, cina, chinchona officinalis, coffea cruda, nux vomica spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-301
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK30 [hp_C]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 59 mL
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT6 [hp_C]  in 59 mL
ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA FLOWER30 [hp_C]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68703-301-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/24/2017
Labeler - Silver Star Brands (006070379)
Registrant - Silver Star Brands (006070379)
Establishment
NameAddressID/FEIBusiness Operations
King Bio617901350api manufacture(68703-301) , manufacture(68703-301)

Revised: 4/2017
Document Id: 4d11cc46-393a-1561-e054-00144ff8d46c
Set id: 4d11cc46-3939-1561-e054-00144ff8d46c
Version: 1
Effective Time: 20170413
 
Silver Star Brands